本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2023.27022

摘要内容如下：

重要性

美国于2022年9月1日建议12岁及以上儿童和青少年接种二价mRNA Covid-19疫苗，于2022年10月12日建议5至11岁儿童接种二价mRNA Covid-19疫苗。然而，证明二价Covid-19疫苗有效性的数据有限。

目的

评估二价CoVID-19疫苗对儿童和青少年中SARS-CoV-2感染和有症状的CoVID-19的有效性。

设计、设置和参与者

2022年9月4日至2023年1月31日期间的数据来自3项前瞻性美国队列研究（共6个地点），用于评估Covid-19疫苗在5至17岁儿童和青少年中的有效性。共有2959名参与者完成了定期调查（人口统计学、家庭特征、慢性疾病和COVID-19症状），并提交了每周自我收集的鼻拭子（不考虑症状）；参与者在出现任何症状时提交额外的鼻拭子。

曝光

从定期调查中获取疫苗接种状况，并用国家免疫信息系统和电子医疗记录中的数据进行补充。

主要成果和措施

使用逆转录聚合酶链反应检测呼吸道拭子中是否存在SARS-CoV-2病毒。无论症状如何，SARS-CoV-2感染均被定义为检测阳性。有症状的COVID-19被定义为在标本采集后7天内出现阳性试验和2个或2个以上的COVID-19症状。Cox比例风险模型用于评估接受二价CoVID-19疫苗剂量的参与者与未接受疫苗或仅接受单价疫苗剂量的参与者之间的SARS-CoV-2感染和有症状的CoVID-19的风险比。根据年龄、性别、种族、民族、基础健康状况、既往SARS-CoV-2感染状况、地理位置、不同位置的流行变异比例和当地病毒流行率对模型进行了调整。

结果

在2959名参与者中（47.8%为女性；中位年龄，10.6岁[IQR，8.0-13.2岁]；64.6%为非西班牙裔（白人），25.4%接种了二价Covid-19疫苗。在研究期间，426名参与者（14.4%）经实验室确认感染了SARS-CoV-2。在这426名参与者中，184人（43.2%）有Covid-19症状，383人（89.9%）未接种或仅接种了单价Covid-19疫苗（每1000人日1.38例SARS-CoV-2感染），43人（10.1%）接种了二价Covid-19疫苗（每1000人日0.84例SARS-CoV-2感染）。针对SARS-CoV-2感染的二价疫苗有效性为54.0%（95%CI，36.6%-69.1%），针对有症状的CoVID-19的疫苗有效性为49.4%（95%CI，22.2%-70.7%）。仅接种单价Covid-19疫苗的参与者接种后的中位观察时间为276天（IQR，142-350天），而接种二价Covid-19疫苗的参与者接种后的中位观察时间为50天（IQR，27-74天）。

结论和相关性

二价CoVID-19疫苗保护儿童和青少年免受SARS-CoV-2感染和有症状的CoVID-19。这些数据证明了Covid-19疫苗对儿童和青少年的益处。所有符合条件的儿童和青少年应及时接种推荐的COVID-19疫苗。

英文原文如下：

Abstracts

Importance  Bivalent mRNA COVID-19 vaccines were recommended in the US for children and adolescents aged 12 years or older on September 1, 2022, and for children aged 5 to 11 years on October 12, 2022; however, data demonstrating the effectiveness of bivalent COVID-19 vaccines are limited.

Objective  To assess the effectiveness of bivalent COVID-19 vaccines against SARS-CoV-2 infection and symptomatic COVID-19 among children and adolescents.

Design, Setting, and Participants  Data for the period September 4, 2022, to January 31, 2023, were combined from 3 prospective US cohort studies (6 sites total) and used to estimate COVID-19 vaccine effectiveness among children and adolescents aged 5 to 17 years. A total of 2959 participants completed periodic surveys (demographics, household characteristics, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (irrespective of symptoms); participants submitted additional nasal swabs at the onset of any symptoms.

Exposure  Vaccination status was captured from the periodic surveys and supplemented with data from state immunization information systems and electronic medical records.

Main Outcome and Measures  Respiratory swabs were tested for the presence of the SARS-CoV-2 virus using reverse transcriptase-polymerase chain reaction. SARS-CoV-2 infection was defined as a positive test regardless of symptoms. Symptomatic COVID-19 was defined as a positive test and 2 or more COVID-19 symptoms within 7 days of specimen collection. Cox proportional hazards models were used to estimate hazard ratios for SARS-CoV-2 infection and symptomatic COVID-19 among participants who received a bivalent COVID-19 vaccine dose vs participants who received no vaccine or monovalent vaccine doses only. Models were adjusted for age, sex, race, ethnicity, underlying health conditions, prior SARS-CoV-2 infection status, geographic site, proportion of circulating variants by site, and local virus prevalence.

Results  Of the 2959 participants (47.8% were female; median age, 10.6 years [IQR, 8.0-13.2 years]; 64.6% were non-Hispanic White) included in this analysis, 25.4% received a bivalent COVID-19 vaccine dose. During the study period, 426 participants (14.4%) had laboratory-confirmed SARS-CoV-2 infection. Among these 426 participants, 184 (43.2%) had symptomatic COVID-19, 383 (89.9%) were not vaccinated or had received only monovalent COVID-19 vaccine doses (1.38 SARS-CoV-2 infections per 1000 person-days), and 43 (10.1%) had received a bivalent COVID-19 vaccine dose (0.84 SARS-CoV-2 infections per 1000 person-days). Bivalent vaccine effectiveness against SARS-CoV-2 infection was 54.0% (95% CI, 36.6%-69.1%) and vaccine effectiveness against symptomatic COVID-19 was 49.4% (95% CI, 22.2%-70.7%). The median observation time after vaccination was 276 days (IQR, 142-350 days) for participants who received only monovalent COVID-19 vaccine doses vs 50 days (IQR, 27-74 days) for those who received a bivalent COVID-19 vaccine dose.

Conclusion and Relevance  The bivalent COVID-19 vaccines protected children and adolescents against SARS-CoV-2 infection and symptomatic COVID-19. These data demonstrate the benefit of COVID-19 vaccine in children and adolescents. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations.

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